Medical Research Council

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Medical Research Council

• http//www.mrc.ac.za
• Building a healthy nation
• through research

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• Indigenous Knowledge Systems Health Lead
  Programme
• Medical Research Council South Africa
• Managing IP and Benefit-sharing on IKS Research
• Presentation to Portfolio Committee on Arts and
  Culture
• Dr Motlalepula G. Matsabisa
• 29th, August 2006

Going back to our roots for innovative health
solution
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Our Mission and Vision
To promote and advance indigenous knowledge
systems through research and development by
making it a valued health model in the global
environment and to redress health traditions,
which until now have neglected health research
priorities and issues. To be a centre of
excellence in traditional medicines research
regionally and to be competitive globally
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Objectives

• Coordination and development of health research
  in indigenous knowledge
• Development of institutional and community
  networks
• Development of an enabling clinical trials
  environment
• Innovations and commercialization in
  traditional health systems.
• Policies governing intellectual property and
  benefit-sharing
• Development of Research programmes that are
  appropriate relevant
• Support academic research
• Funding

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Organizational Structure
CEO
EXECUTIVE RESEARCH
DELFT SUPPORT STAFF
IKS LEAD PROGRAMME
PA


SOCIAL IMPACT
IKS UTILISATION
RESEARCH DEVELOPMENT
KNOWLEDGE MANAGEMENT



Malaria Hypertension HIV and AIDS Tuberculosis Can
cer Diabetes
Training Capacity Development Databases Advocacy
Policy Access and Beneficiation
Databases GPS Claims for Cures Monographs Tramed
III
SBU Spin-out Companies IKS Research
Commercialization Drug Manufacturing
Job Creation Poverty Alleviation Capacitation Ent
repreneurial development Business development
PPCP for job creation Ownership and
Empowerment Sustainable community business
enterprises
Drug Discovery Development New Method
development Systems Biology Platform Clinical
Trial Platform Toxicology









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Clinical Evidence for TM
Based on 50 RCTs evaluating 10 TM for 18
indications (Therapeutics Letter, Issue 25, June
July 1998)
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TM Research Platforms

• Platforms
• Old Monkey Plasmodium falciparum model efficacy
• Clinical trial platform
• Malaria, Diabetes, Hypertension
• Systems biology platform
• Metabolimics
• Proteomics
• Genomics
• Drug Targets
• Reversal of Parasite / Virus resistance

• Preclinical studies
• Toxicology
• Antimutagenicity / Mutagenicity
• Genotoxicity
• Carcinogenicity
• Metabolism
• TM QA / QC
• Clinical studies
• Safety studies
• e.g. Immune modulators
• Efficacy studies
• e.g. Immune modulators

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Clinical Trials

• Observational studies
• 3 Month Observational study
• THP is collaborator
• Clinicians Clinical and Pathological evaluations

• Ethics
• Ethics
• Subject Information for screening
• Informed consent for screening
• Informed consent for HIV testing
• Subject information for participation in the
  study
• Informed consent for participation in the study
• Information leaflet for participation in the
  study
• Counseling
• Integrated approach To whole
  family
• Pre-screening HIV counseling
• 1 post screening counseling (referral of
  those that are HIV, but not meeting the
  inclusion criteria to appropriate accredited
  centres for support)
• Ethical approval (scientific and ethical
  merits)
• Protocols are peer-reviewed
• Submitted to ECRA (Animal ethics review)
• Submitted to MRC MCCs Clinical Trials
  Committee CTC) for ethical evaluation

• Toxicology
• 90-day sub chronic study on a non-human primate
  model
• Minimum animals 16 Duration 3 months

• Clinical Trials
• Phase II/III
• Are double blind, randomized, placebo controlled
  dose elevation parallel group studies
• Phase I Minimum participants 20 Duration 12
  weeks
• Phase II Minimum participants 40 Duration 6
  months (9 12)

Indemnity Insurance For all trialists and
participants in Phase I and II studies
Complete CV of all Trialists Complete contact
details of all trialists including that of
chairperson of Ethics committee
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Medicinal Trade in South Africa

• 1988 1996 750 plant species used in
  Traditional Medicines
• - 200 very
  infrequently traded
• 24
  000 sp of plants in SA
• 
  4 000 used in Traditional medicines
  
• 
  (used by approx. 12-15 million people)
  
• 20 000t
  medicinal plants traded/year - US60million
• 1996 4300t of wildlife
  medicinals traded in KwaZulu-Natal -
• US13.3million
  
• 1997 750t traded in Mpumalanga
  US2.25million

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Facts

• 74 of drugs developed from plants could be
  attributed to the use of indigenous plants in
  traditional medicine by various communities
  (Wambembe, 1999).
• The annual sales of drugs developed from
  traditional medicines amounted to US43bn out of
  the US130 000bn total sales of pharmaceuticals
  in the 1980s (Rural Advancement Fund Int. 1997).
• Less than 0.001 of profits from plant-based
  drugs from traditional medicine knowledge accrued
  to the people who provided the leads for the
  research (Posey, 1991).
• Approximately 80 of the rural population use
  traditional medicines.

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Drugs from Plants

• Drug Use
  Source
• Aspirin Pain
  killer Wild willow
• Theophylline Asthma
  Theobroma tree
• Digitoxin / Digoxin Heart failure
  Digitalis purperieae
• Artemisinin Antimalarial
  Artemisia annua
• Vincristine/ Vinblastine Anticancer
  Catharanthus roseus
• Quinine
  Antimalarial Cinchona
• Penicillin
  Antibacterial Fungus
• Cyclosporine
  Immunosuppressant Fungus
• Tachrolymus FK506 Immunosuppressant
  Fungus

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Handling of IP and Beneficiation
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South Africas Brief Progress

• IKS Bill 2002
• To recognize, promote, develop, protect and
  affirm the hitherto undermined and marginalized
  Indigenous Knowledge Systems (IKS)
• To contribute to the reclamation and realization
  of indigenous knowledge of South Africas diverse
  communities and value systems connected
  therewith
• and to establish a regulatory framework for IKS
  and matters connected therewith.

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IKS Proposed Bill 2002

• The objectives of the Bill are
• To give legal recognition to Indigenous Knowledge
  (IK) and Indigenous Knowledge Systems (IKS) and
  IK practitioners
• To establish principles to guide and manage the
  recognition, promotion, development, innovation
  and protection of IK and IKS
• To regulate forms of ownership and benefit
  sharing of IK and IKS at all levels of value
  addition

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IKS Proposed Bill 2002

• To provide mechanisms for the capacity building
  of IK practitioners including their education,
  training, capacitation, development, empowerment
  and ownership
• To promote research and development activities in
  the area of IK and IKS
• To promote public awareness of IK and IKS
• To establish a regulatory mechanism called the
  Indigenous Knowledge Systems Authority to
  assist in achieving the above

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Countrys Processes

• DST- IKS Policy 2005
• DST- IP from Public funded/financed Research,
  2006
• DEAT- Biological Diversity Act no 10, 2004
• DEAT- National Environmental Management
  Biodiversity Act, 2005
• DOH - Traditional Health Practitioners Act, 2005?
• DOH - Traditional Medicines Committee of MCC
• AGRIC- Draft Policy on Protection of Indigenous
  Seeds, 2006
• AGRIC- Plant Breeders Rights
• UNESCO- Safeguarding and Protection of Intangible
  Heritage, 2003
• DST- National Office of IKS, 2006

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Countrys Processes

• DST-TKDL approach - Documentation by National
  Biodiversity Institutions, MRC Centre for
  Scientific and Industrial Research
• DTI Amendment Patent Law IKS protection
• DTI-Patent Amendment Bill no.17 of 2005 -To amend
  the Patent Act ,1978, so as to insert certain
  definitions and to require am application for a
  patent to furnish information relating to any
  role played by an indigenous biological or
  genetic resource or TK or use in an invention
  and to provide for matters connected therewith
• DTI- IP IK Protection Policy Interfacing
  protection and commercialisation of traditional
  knowledge systems with the existing intellectual
  property system.
• DTI - Protection and Commercialization of TK
  within the existing IP systems (Draft)
• DST - Framework for IP from Publicly Financed
  Research (Draft)

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IKS POLICY1

• The Indigenous Knowledge Systems (IKS) Policy is
  an enabling framework to stimulate and strengthen
  the contribution of indigenous knowledge to
  social and economic development in South Africa.
  The main IKS Policy drivers in the South African
  context include the
• Affirmation of African cultural values in the
  face of globalisation a clear imperative given
  the need to promote a positive African identity
• Practical measures for the development of the
  economic value of services provided by indigenous
  knowledge holders and practitioners involved in,
  among others, traditional medicine, technologies,
  spirituality, and indigenous languages

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IKS POLICY2

• Underpinning the contribution of indigenous
  knowledge to the economy the role of indigenous
  knowledge in employment and wealth creation and
  innovation and
• Interfaces with other knowledge systems, for
  example, indigenous knowledge is used together
  with modern biotechnology in the pharmaceutical
  and other sectors to increase the rate of
  innovation

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Challenges for IK Protection

• In the South African context there is a need for
  the formulation and development of a Policy that
  will also address the following problems
• Lack of due process of the law to address the
  protection of IKS.
• Lack of due process of the law to address
  commercialization of IKS.
• Lack of due process of the law to empower
  collective holders of IKS.
• Lack of due process of the law to beneficiate the
  holders of IKS.
• Lack of due process of the law to effect
  technology transfer.
• Lack of a legal framework to address development,
  economic, social and socio-economic issues

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Benefit-sharing ModelPoverty Alleviation
1/2
1/2
National (Bioprospecting) Trust Fund Indigenous
community and traditional healers
MRC
?
1/3
2/3
1/2
?
Different communities Companies jointly
with Private Partners
Local Trust Fund Specific for Traditional
Healers and their specific Community Trustees Trad
itional Healers their Communities and
Research/ Funding Institution
Investigators
Re-invest into IKS Research
?
Individuals who supplied the Information /or
the Genetic material
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The Benefit-sharing Model Consortia
1/2
1/2
National Trust Fund Indigenous communities and
traditional healers
CONSORTIUM of Institutions
1/2
X5
X1
X2
X3
X4
Xn
Trust Account / s For Different communities
and Traditional doctors
Local Trust Fund Specific Traditional Healers
and their specific Community Trustees
Traditional Healers , their communities
Consortium
?
?
Investigators
Re-invest into IKS development, education
research
?
Individuals who supplied Information /or the
Genetic material
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Monetary Non-monetary

• Seven Models
• Individuals
• Individual, goes into community
  project
• Finite period for
  benefit-sharing
• Authentification of novelty
  and ownership
• University Model
• Consortia Model
• International Collaboration
• Each country to have its own
  model for its community
• Country where source of
  innovation, has the final say in benefit-sharing
  model
• Poverty Alleviation model
• Community as majority
  shareholder with over 51 control on business
• Community not allowed to
  sell their shares
• Selling or rights of IK to be a national decision
  a partnership approach encouraged

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Concluding Remarks1

• National policies political mandate and
  public-private-community partnership
• Budget and inter-governmental relations
• Observations on and implications of
  International instruments e.g. CBD, TRIPS-WTO
• Best Practices in Africa and Developing Countries
  (South-South relation)
• NEPAD AU country participation

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Concluding Remarks2

• Multi-lateral and bilateral agreements
• Capacity Building and Educational Awareness
• WIPO intergovernmental Committee - participation
  and implementation
• No single government Department has a monopoly on
  IKS protection its Development
• FINALLY South Africas IKS POLICY to be
  Launched internationally at WIPO a sign of hope
  for sui generis.
• Liability clauses

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http//www.mrc.ac.za Building a healthy nation
through research